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BIG for Life: a Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090476
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Amy DeBlois, State University of New York - Upstate Medical University

Brief Summary:

This research study will aim to evaluate BIG for LIFE as a group exercise program, and determine whether three time a week exercise sessions with heart rate monitoring is beneficial to maintain or improve physical function, cognitive function, and quality of life over a period of 8 weeks (pre/post testing and 24 visits).

The specific objective of this study is to investigate the impact of this exercise group (BIG for LIFE) on motor functions (i.e. balance, gait, strength, balance confidence) and quality of life functions (sleep, depression, activities of daily living)

The investigators will test the following hypotheses:

  1. that participation in this community-based exercise group will improve mobility level and balance confidence
  2. that participation in this group will increase performance of activities of daily living as measured by self-assessment
  3. that participation in this group will increase quality of life, cognition, sleep, or depression measures
  4. that providing real time heart rate feedback in this group setting will increase the amount of time spent exercising in the target heart rate zone

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Exercise Not Applicable

Detailed Description:

Study participants will complete a total of 24 exercise sessions (in person or via Zoom). At the initial session, participants will undergo screening and consent, physical assessments (10 meter walk test, 6 minute walk test, 5 Times Sit to Stand, and the Mini Bestest) and routine baseline medical assessments (Appearance, Pulses, BP) and complete self-assessments regarding balance (Activities Balance Confidence Questionnaire, ABC) and cognitive assessment with Trails A/B, quality of life (PDQ-39,PHQ-9, PDSS-2, FOG-q, and Patient-Specific Functional Scale); these assessments will be repeated at the final visit. In person assessments preferred but if unable due to health regulations they can be administered virtually. For virtual assessments the miniBESTest and 6 minute walk test will not be administered, all others can be administered virtually. Questionnaires will be mailed as well as instructions/materials for physical assessments for virtual assessments. Physical assessments will occur via zoom with help from family member or other individual. Participants will be also instructed in use of the heart rate monitor and will be instructed in importance of exercising at a moderate intensity.

During each of the exercise sessions the LSVT Big daily exercises will be performed along with functional tasks and gait/balance tasks. The functional tasks and gait/balance tasks will change weekly to monthly and all activities will be modified to the participant's mobility level. We will compare changes in assessment and questionnaire scores before and after completion of the 8-week (24 exercise sessions) intervention, anticipating that participants will either improve or not experience significant degradation of cognitive, physical or motor function, as can be observed in PD patients after completion of the exercise program.

Upon completion of the 8-week exercise program, assessments and questionnaires will be repeated, and the participants will be interviewed to gain anecdotal insight into their experience with the program. Using the rolling enrollment strategy, we will be able to accumulate data to provide interim insight into the progress on our study objectives, and to assess whether the number of subjects estimated is appropriate to achieve statistical power to support or reject our hypotheses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a High Intensity Community Exercise Group (BIG for Life) on Motor Function (i.e. Balance, Gait, Strength, Balance Confidence), Ability to Perform Activities of Daily Living, and Quality of Life Measures in Individuals With Parkinson's Disease.
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : May 13, 2022
Estimated Study Completion Date : September 13, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIG for Life Exercise Group
This arm includes the entire cohort enrolled who will participate in the three times a week one hour community exercise group for a total of 8 weeks
Other: Exercise
During each of the exercise sessions the LSVT Big daily exercises will be performed along with functional tasks and gait/balance tasks. The functional tasks and gait/balance tasks will change weekly to monthly and all activities will be modified to the participant's mobility level.




Primary Outcome Measures :
  1. Change in Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    The PDQ-39 is a 39 item self-report questionnaire which assesses Parkinson's disease specific health related quality over the last month across 8 quality of life dimensions (activities of daily living, attention and working memory, cognition, communication, depression, functional mobility, quality of life, social relationships, social support). Items are answered on a 5 point ordinal scale (0=never, 1=occasionally, 2=sometimes, 3=often, 4=always) Lower scores reflect better quality of life. The sum of scores is divided by the maximum score and multiplied by 100.

  2. Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Scores are added and divided by 27. Depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

  3. Change in Parkinson's Disease Sleep Scale - Version 2 (PDSS-2) [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    The PDSS-2 is a 15 item self-report questionnaire specific to sleep quality for individuals with Parkinson's disease. It uses a 5 point scale (04=very often, 3=often, 2=sometimes, 1=occasionally, 0=never) Score ratings are added and lower scores correlate with better sleep quality.

  4. Change in Freezing of Gait Questionairre (FOG-q) [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    FOG-Q is a 16 item self-report measure used to asses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease. There are 6 items (4 items assess FOG severity and 2 items assess gait). Responses use a a 5-point ordinal scale from 0 (absence) to 4 (most severe). Total scores range from 0 to 24 with higher scores indicating more severe FOG.

  5. Change in Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    The Activities-specific Balance Confidence (ABC) Scale is a 16-item questionnaire/survey. Each item is rated from 0% (no confidence) to 100% (complete confidence) A higher score indicates more balance confidence.

  6. Change in 5 times sit to stand [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    Lower extremity strength measure

  7. Change in 3M Backwards Walk Test [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    Timed measure of Backwards Walk over the distance of 3M.

  8. Change in 10 meter walk test [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    Gait speed measure

  9. Change in 6 minute walk test [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    Walking Endurance Measure

  10. Change in Mini-BESTest [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    The Mini-BESTest is a measure of dynamic balance, functional mobility, and gait. It consists of 14 items under the sections of anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. It is scored out of 28 points with a 3-level ordinal scale (0-2) with higher scores indicating better balance.

  11. Change in Patient Specific Functional Scale (PSFS) [ Time Frame: Baseline and 8 weeks later (after 24 recorded exercise sessions) ]
    This is a questionnaire to quantify activity limitation and measure functional outcomes. Participants choose up to 7 functional activities to rate on an 11 point ordinal scale from 0=unable to perform activity to 10= able to perform at the same level as before the problem. Total score=sum of the activity scores/number of activities.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People with Parkinson's disease age 18 or over, male or female will be included.

Exclusion Criteria:

  • Persons under the age of 18 and those without a diagnosis of Parkinson's disease will be excluded from the study. Individuals with PD who are bed bound or wheelchair bound will be excluded. Scores of <23 on the MOCA will be excluded due to risk of cognitive impairments which may limit participation and ability to consent. Participants must be cleared for participation in the community exercise program by their physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090476


Contacts
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Contact: Amy DeBlois, DPT 315-464-6885 debloisa@upstate.edu

Locations
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United States, New York
Rock Steady Boxing Gym Recruiting
Liverpool, New York, United States, 13088
Contact: Amy DeBlois, DPT    315-464-6885    debloisa@upstate.edu   
Sponsors and Collaborators
State University of New York - Upstate Medical University
Publications:

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Responsible Party: Amy DeBlois, Assistant Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT04090476    
Other Study ID Numbers: 1441170
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy DeBlois, State University of New York - Upstate Medical University:
community exercise group
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases